Application 213592

Type: ANDA
Sponsor: CENTAUR PHARMS PVT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	TABLET, EXTENDED RELEASE;ORAL	6.25MG	No	No
002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	TABLET, EXTENDED RELEASE;ORAL	12.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213592-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB		2020-06-04
A213592-002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2020-06-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A213592-001	AB
A213592-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`87673890dc5c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213592-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213592-002	AB	1	`011fe1cb6892…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213592-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213592-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213592-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213592-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213592-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213592-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213592-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213592-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213592-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213592-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213592-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213592-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213592-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A213592-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213592-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A213592-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213592-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A213592-002	AB	1	`c0c555d07b60…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213592-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213592-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213592-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213592-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213592-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A213592-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213592-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A213592-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213592-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213592-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213592-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A213592-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213592-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A213592-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213592-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213592-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213592-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213592-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Breckenridge Pharmaceutical, Inc.	cbda91f7-4411-4016-80d6-0a349931956d	2025-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213592 application number: ANDA213592 ndc (product): 51991-981 ndc (product): 51991-982
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Asclemed USA, Inc.	35f6c1ab-a61c-4625-b932-11a7483f1d84	2022-10-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213592 application number: ANDA213592 ndc (product): 76420-496 ndc (product): 76420-494

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51991-981	Zolpidem Tartrate	Zolpidem Tartrate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-981	Zolpidem Tartrate	Zolpidem Tartrate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-982	Zolpidem Tartrate	Zolpidem Tartrate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-982	Zolpidem Tartrate	Zolpidem Tartrate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
55700-971	Zolpidem Tartrate	Zolpidem Tartrate	Quality Care Products, LLC	ANDA	Current
64330-623	Zolpidem Tartrate	Zolpidem Tartrate	Centaur Pharmaceuticals Private Limited	ANDA	Current
64330-624	Zolpidem Tartrate	Zolpidem Tartrate	Centaur Pharmaceuticals Private Limited	ANDA	Current
68788-8118	Zolpidem Tartrate	Zolpidem Tartrate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8118	Zolpidem Tartrate	Zolpidem Tartrate	Preferred Pharmaceuticals Inc.	ANDA	Current
76420-494	Zolpidem Tartrate	Zolpidem Tartrate	Asclemed USA, Inc.	ANDA	Current
76420-496	Zolpidem Tartrate	Zolpidem Tartrate	Asclemed USA, Inc.	ANDA	Current